EUCTR2006-000113-38-GB进行中（未招募）1 期
A randomised phase II double blind placebo controlled trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer (NSCLC) with multiple brain metastases - TACTIC
niversity College London0 个研究点目标入组 144 人开始时间: 2006年12月7日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a) Histologically or cytologically confirmed NSCLC. A biopsy of metastatic disease in the brain is not required for study enrolment.
- •b) Patients with newly diagnosed single or multiple brain metastases in whom immediate chemotherapy is not required for palliation of systemic extra-cranial disease. Patients with a solitary brain metastasis are only eligible for the trial providing they are not suitable for stereotactic radiotherapy or surgical resection.
- •c) Diagnosis of brain metastases must be confirmed on MRI or contrast CT scan.
- •d) Able to start treatment within 4 weeks of the baseline measurement scans of the brain, chest & abdomen.
- •e) Patients with post-craniotomy incomplete resection will be permitted.
- •f) No prior cranial radiotherapy.
- •g) = 28 days from any chemotherapy to Day 1 of trial treatment.
- •h) Clinician certain of the role of WBRT.
- •i) Glasgow Coma Score =14.
- •j) Karnofsky performance status = 70, RTOG RPA class I and II (modified by age to <76 years).
- •k) Maximum of 3 sites (organ systems) of extracranial metastases (not including lung primary).
- •l) Age > 18 years and < 76 years.
- •m) Able to take oral medication.
- •n) Adequate renal function, serum creatinine <1.5 x ULN and C&G GFR >40ml/min, absence of evidence of acute renal failure.
- •m) Adequate liver function, ALT or AST < 2 x ULN without liver metatases or < 5 x ULN with liver metatases; serum bilirubin < 2 x ULN.
- •o) Willing to use effective contraception, if of reproductive potential, whilst on trial drug and for at least 2 weeks after completing trial drug. (Women of childbearing potential must have a negative pregnancy test performed by a healthcare professional prior to randomisation.)
- •p) Willing and able to give informed consent.
- •q) Willing to participate in the biological study.
- •r) Carer able and willing to participate.
- •s) Patient and carer with access to telephone and willing to respond to telephone interview.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a) Presence of a solitary brain metastasis suitable for stereotactic radiosurgery or surgical resection.
- •b) Patients who require immediate chemotherapy for symptom control.
- •c) Clinician certain that WBRT will NOT be of benefit.
- •d) Clinician uncertain of the role of WBRT.
- •e) Previous treatment with any EGFR anti-cancer therapy (e.g. Tarceva, Iressa or Cetuximab).
- •f) Previous treatment for brain metastases (radiosurgery, radiotherapy or chemotherapy) - however prior radiotherapy or surgery to the primary tumour and/or systemic treatment to metastatic sites of disease is acceptable.
- •g) Glasgow Coma Score < 14.
- •h) Pregnant or lactating women.
- •i) Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications. For example:
- •-Severe uncontrolled infection
- •-Cardiovascular: unstable angina, myocardial infarction within 1 month
- •-Gastro-intestinal: uncontrolled inflammatory bowel disease (e.g. Crohn’s or ulcerative colitis)
- •-Hepatic: serum bilirubin = to 2x upper limit of normal (ULN), serum transaminases = 2x ULN in the absence of liver metastases or = 5x ULN with liver metastases
- •-Renal: acute renal failure, serum creatinine =1.5 x ULN.
- •j) Other previous or current malignant disease likely to interfere with protocol treatment or comparisons.
- •k) Current treatment with Cox II inhibitor.
- •l) > 75 years of age.
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